Listed medicine compliance review reports database March 2025 update

The Listed medicine compliance reports database has been updated to include our latest compliance review results for 37 listed medicines.

The listed medicines covered in this round of updates include medicines containing valerian ingredients, lysine hydrochloride for cold sore management, and Vitamin D for claims relating to bone. This update also includes medicines making non-permitted claims about attention deficit hyperactivity disorder (ADHD), asthma, cardiovascular diseases, diabetes, exercise performance, and urinary frequency.

For more information about medicines subject to a review and the compliance review process, refer to the database and the information on Listed medicine compliance reviews.

What are listed medicines and how are they regulated?

Listed medicines have an ‘AUST L’ number on the label and packaging, and include products such as vitamins and minerals, traditional Chinese medicines, herbal medicines and some sunscreens.

These medicines are included in the Australian Register of Therapeutic Goods (ARTG) and can be sold without being checked by the TGA for safety, quality and effectiveness. Instead, sponsors of listed medicines certify that their medicine meets all the relevant legal requirements prior to selling them.

Listed medicines can only contain ingredients that we have assessed to be of low risk. Their indications (therapeutic uses) can only be selected from a pre-approved list. The indications of a listed medicine on its label, packaging or other advertising material must be included in the ARTG entry of the medicine and must be supported by evidence.

We regularly conduct post-market compliance reviews of selected listed medicines to check for compliance. If a medicine is found to not comply with the legal requirements, we take risk-based and proportionate regulatory actions to address the non-compliance.

We publish the outcomes of these compliance reviews on the Listed medicine compliance reports database on a quarterly basis to allow timely public access to safety or efficacy information of reviewed listed medicines. This assists consumers to make informed decisions when self-selecting listed medicines and avoid purchasing a product that may not be appropriate for them.